Quota Applications

Background:

Each year the United States sets the Aggregate Production Quotas (APQ) for Schedule I and II controlled substances and the Annual Assessment of Needs (AAN) for the Combat Methamphetamine Epidemic Act (CMEA) List I chemicals — ephedrine, pseudoephedrine, and phenylpropanolamine — which determine the annual quantities of controlled substances and List I chemicals available for national medical, scientific, and industrial use.

The following entities must apply for a quota:

Manufacturers of Schedule I and II controlled substances.

Manufacturers of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Importers of the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

Only those persons registered by the Drug Enforcement Administration to manufacture Schedule I or II controlled substances, or import or manufacture the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine, including drug products containing those List I chemicals, may submit applications for quotas.

Deadlines:

Annual applications for quotas must be filed on or before the date indicated of the year preceding the calendar year for which the quota is being applied.

DEA Form 189 for Manufacture Quotas must be filed on or before May 1.

DEA Form 250 for Procurement Quotas must be filed on or before April 1.

DEA Form 488 for Import Quotas must be filed on or before April 1.

Separate applications are required for each basic drug class requested. Registrants with new registrations or newly added drug codes may apply for quota at any time. Registrants may request adjustments to their current quotas at any time.

In order to complete your firm’s year-end reports using Quotas Online, a "corporate administrator" will need to obtain a username and password. Generally, a corporate administrator is the person at your manufacturing location(s) responsible for filing quota applications or has oversight of this process. Corporate users will be responsible for creating, modifying, and deleting individual user accounts within your organization. DEA will only issue one (1) corporate user account per registration.

In order for a corporate administrator to obtain a username/password from DEA, the following user agreement (PDF) must be completed and faxed to the UN Reporting and Quota Section at 202-598-8262. Scanned user agreements in *.pdf format may also be emailed to DEAQuotas@usdoj.gov (please note "Quota and YERS Access" in the subject line).

Upon receipt and verification of your user agreement, DEA will send the corporate administrator an email with the username, password and web address with the login screen for both Quotas Online and YERS Online.

A user guide (PDF) has been prepared to assist users in navigating through the application.

Reporting Quotas via US Postal Service

It is suggested that you review the instructions prior to completing the forms. The fillable PDF forms may be completed online then printed on your computer.